Consultant, Manufacturing and Supply (Contract)

Kyverna Therapeutics • Boston, MA, USA • $45 - $60 / hour • 1d ago

Kyverna is recruiting a Consultant, Manufacturing and Supply (Contract) in its Tech Ops organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual humility, elevate each other, and stay true to why.

This role will be responsible for supporting the management of change controls and project execution, manufacturing procedure/workflow development, project management, execution of tasks as assigned and have PIP responsibilities within the network of CDMOs. They will execute tactical planning and provide project management support to ongoing continuous improvement opportunities.

Consultant, Manufacturing and Supply (Contract)

Location: Boston, MA - 3-4 days a week

Assignment length: Approximately 6+ months

Hourly Rate: $45.00 - $60.00/hr

Responsibilities

Perform Person-in-Plant activities within the network of CDMOs.
Support execution of Change Controls, ensuring all assigned activities occur as planned and all implementation actions are coordinated to ensure robust supply of product to patients.
Use operational excellence mind-set and tools to review processes, procedures, and documentation to maintain simplicity, accuracy and robustness in the operational approach.
While creating and improving documentation, process flows and internal business processes, will proactively work with internal and external stakeholders to evaluate business needs and collaborates with and executes on projects as needed to support Manufacturing. Processes related to interfaces and coordination between Kyverna and its external CDMOs, interfaces with internal quality and supply chain to support improvements in Vein to Vein time, supporting regulatory filings and continuous improvement.
In collaboration with program teams, execute and support program goals, including document revision and process definition.
Provide support for CDMOs and strategic suppliers to ensure overall program deliverables are achieved.
Evaluate capabilities and industry best practices to identify new opportunities for optimization and innovation in clinical manufacturing.
Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
Participate in Risk Based Quality Management strategies in support of Kyverna’s clinical programs.
Other duties as assigned.

Requirements

Bachelor’s degree or higher in life sciences, Biochemistry, Chemical Engineering, Biotechnology.
2+ years of pharmaceutical manufacturing, technology transfer & process development experience with at least 1 years’ experience in the field of cell therapies.
Knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biopharmaceutical products and ATMPs.
Knowledge and experience in manufacturing operations for clinical trial products and aseptic processes, with an emphasis on cell therapies.
Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
Excellent interpersonal, verbal and written communication skills
Ability to function efficiently and independently in a changing environment.
Manage and advance multiple projects simultaneously and dynamically reprioritize as needed.
Demonstrated success in leading high performing teams.
Ability to communicate effectively with Kyverna Leadership and with external business partners and Regulatory Authorities.